~ Updated clearance incorporates various instrument upgrades, as well as per-procedure costs, improving unit economics driven by the reclassification of certain instruments from disposable to reusable status ~
~ Clearance reflects Tenon’s commitment to continuous innovation and operational efficiency, with reusable instrumentation expected to drive lower capex and logistical spend, contributing positively to gross margins and cash flow ~
LOS GATOS, CA / ACCESS Newswire / July 2, 2026 / Tenon Medical, Inc. (NASDAQ:TNON) (“Tenon” or the “Company”), a company transforming care for patients suffering with certain sacro-pelvic disorders, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Catamaran® SI Joint Fusion System.
The updated clearance incorporates various instrument upgrades, as well as the reclassification of certain instruments from disposable to reusable status. These enhancements are designed to further improve the performance of the Catamaran System while delivering meaningful economic benefits to the Company by eliminating ongoing per-procedure costs previously associated with disposable instrumentation.
“This 510(k) clearance reflects our ongoing commitment to never-ending refinement of our Catamaran System – not only for the physicians who rely on it and the patients who depend on it, but also for the long-term financial health of our business,” said Steven M. Foster, President and CEO of Tenon. “The instrument upgrades advance the procedural performance that our surgeon users have come to expect from the Catamaran platform, and the transition of select instruments from disposable to reusable status is a smart operational improvement that will reduce our per-procedure cost structure and contribute positively to our gross margins going forward. As we continue to drive commercial adoption across our growing portfolio, initiatives like this demonstrate that we are focused on building a sustainable, scalable business.”
The Catamaran SI Joint Fusion System offers a novel, minimally invasive approach to the sacroiliac joint, utilizing a single, robust titanium implant that stabilizes and transfixes the SI joint along its longitudinal axis. The implant’s inferior-posterior surgical approach is designed to navigate away from critical neural and vascular structures and into the strongest cortical bone. Since its national launch in October 2022, there have been over 1,500 Catamaran Fixation Devices implanted in patients throughout the United States suffering from sacroiliac joint disruptions and degenerative sacroiliitis.
